PMID- 28815005
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2001-8525 (Print)
IS  - 2001-8525 (Electronic)
IS  - 2001-8525 (Linking)
VI  - 4
IP  - 1
DP  - 2017
TI  - Phase I study evaluating the safety, tolerability and pharmacokinetics of a novel 
      oral dissolvable film containing dexamethasone versus Fortecortin dexamethasone 
      tablets.
PG  - 1353395
LID - 10.1080/20018525.2017.1353395 [doi]
LID - 1353395
AB  - Introduction: Systemic corticosteroids are anti-inflammatory agents with 
      dexamethasone among the most potent in the class. Within (respiratory) allergy, 
      systemic corticosteroids are usually applied in medical emergencies. In these 
      situations, patients may experience physical or logistic problems taking tablets. 
      To fulfil a practical unmet need for outpatients, Dexa ODF, an oral dissolvable 
      film containing dexamethasone, was developed. Objectives: We compared the safety, 
      tolerability and pharmacokinetics (PK) of Dexa ODF with Fortecortin tablets in 
      healthy subjects. Methods: Thirty subjects participated in this open label, 
      two-way, cross-over study, consisting of two treatment visits separated by 
      5-10 days. On both treatment visits, subjects randomly received one single dose 
      of Dexa ODF (one strip; 8 mg dexamethasone) or one single dose of Fortecortin 
      (two 4 mg tablets). Safety evaluations and blood sampling for PK were conducted 
      until 48 h post-dose and bioequivalence analysis was performed on AUC(0-t), 
      AUC(0-infinity) and Cmax. Results: All subjects were dosed. Forty-five adverse events 
      (AEs) were reported by 17 subjects and approximately 50% were deemed 'possibly 
      treatment related' (14 on Dexa ODF; 12 on Fortecortin) with no significant 
      difference between treatments. For all three bioequivalence parameters the 90% 
      CIs were within the acceptance limits of bioequivalence (0.8;1.25). Conclusion: 
      We demonstrated good tolerability and bioequivalence of Dexa ODF (8 mg 
      dexamethasone) compared to Fortecortin tablets (2 x 4 mg dexamethasone). Dexa ODF 
      is currently under development as an innovative treatment for use within 
      respiratory and allergic conditions, including emergencies.
FAU - Diamant, Zuzana
AU  - Diamant Z
AD  - Department of Respiratory Medicine & Allergology, Institute for Clinical Science, 
      Skane University Hospital, Lund, Sweden.
AD  - Department of Clinical Pharmacy & Pharmacology, General Practice & QPS-NL, 
      Groningen, The Netherlands.
FAU - Samuelsson Palmgren, Gabriella
AU  - Samuelsson Palmgren G
AUID- ORCID: 0000-0002-3761-2380
AD  - Clinical Trial Unit, Clinical Studies Sweden- Forum South, Skane University 
      Hospital, Lund, Sweden.
FAU - Westrin, Bengt
AU  - Westrin B
AD  - AcuCort AB, Helsingborg, Sweden.
FAU - Bjermer, Leif
AU  - Bjermer L
AD  - Department of Respiratory Medicine & Allergology, Institute for Clinical Science, 
      Skane University Hospital, Lund, Sweden.
LA  - eng
PT  - Journal Article
DEP - 20170803
PL  - United States
TA  - Eur Clin Respir J
JT  - European clinical respiratory journal
JID - 101662134
PMC - PMC5553100
OTO - NOTNLM
OT  - Dexamethasone
OT  - allergy
OT  - anaphylaxis
OT  - drug formulation
OT  - pharmacokinetics
OT  - phase 1 clinical trials
EDAT- 2017/08/18 06:00
MHDA- 2017/08/18 06:01
PMCR- 2017/08/03
CRDT- 2017/08/18 06:00
PHST- 2017/03/23 00:00 [received]
PHST- 2017/07/03 00:00 [accepted]
PHST- 2017/08/18 06:00 [entrez]
PHST- 2017/08/18 06:00 [pubmed]
PHST- 2017/08/18 06:01 [medline]
PHST- 2017/08/03 00:00 [pmc-release]
AID - 1353395 [pii]
AID - 10.1080/20018525.2017.1353395 [doi]
PST - epublish
SO  - Eur Clin Respir J. 2017 Aug 3;4(1):1353395. doi: 10.1080/20018525.2017.1353395. 
      eCollection 2017.